Study of a Transdiagnostic, Emotion-focused Group Intervention for Young Adults With Substance Use Disorders

Not Applicable

Completed

• Conditions: Substance Use Disorders; Depression; Anxiety; Emotional Disorder; Suicidal Ideation; Suicidal and Self-injurious Behavior
• Interventions: Behavioral: Unified Protocol (UP); Other: Treatment as Usual (TAU)

• Registration Number: NCT03315208
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The overall aim of this pilot study is to conduct a preliminary trial to evaluate the acceptability and feasibility of adding a transdiagnostic, emotion-focused group intervention (the Unified Protocol, UP) to treatment as usual (TAU) in a comprehensive outpatient program for adolescents and young adults with substance use disorders and emotional distress. Only patients seeking services or engaged in care at an existing outpatient program at MGH (the Addiction Recovery Management Service) are eligible for participation.

Detailed Description

Young adults with substance use disorder (SUD) commonly experience co-occurring emotional distress in the form of affective/emotional disorders (i.e. anxiety, depressive, and related disorders) and self-injurious thoughts and behaviors (SITBs). Based on the conceptualization of emotion dysregulation as a transdiagnostic treatment target, the current study utilizes the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) to target core psychopathological processes related to emotion dysregulation that underlie SITBs and emotional disorder pathology. Given its transdiagnostic format, the UP has the potential to address comorbidity among the emotional disorders (and other functionally similar problems such as SUDs) simultaneously and more comprehensively than single-diagnosis treatments.

Patients seeking services or currently engaged in care at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders (the MGH Addiction Recovery Management Service) are eligible for this study. Participants will be randomized 2:1 to receive either UP + TAU or TAU alone. The adjunctive UP intervention consists of 16 twice-weekly group sessions (delivered over an 8-week period) designed to deliver transdiagnostic, emotion-focused CBT strategies.

Study Timeline

• Study First Submitted: 2017-10-04
• Study First Submitted QC: 2017-10-16
• Study First Posted: 2017-10-20
• Study Start: 2017-11-22
• Primary Completion: 2019-09-20
• Study Completion: 2019-09-20
• Results First Submitted: 2020-09-29
• Status Verified: 2021-03
• Results First Submitted QC: 2021-03-05
• Last Update Submitted: 2021-03-05
• Results First Posted: 2021-04-01
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

1. Young adults ages 18 to 26, inclusive

2. English language proficiency

3. Ability to provide written, informed consent

4. Ability to attend in-person, outpatient sessions

5. Has provided consent to receive or is currently undergoing treatment at the MGH Addiction Recovery Management Service

6. Documented DSM-5 SUD diagnosis (limited to alcohol use disorder; cannabis use disorder; phencyclidine or other hallucinogen use disorder; inhalant use disorder, opioid use disorder; sedative, hypnotic, or anxiolytic use disorder; stimulant use disorder; other (or unknown) SUD)

7. Current elevated emotional distress, as evidenced by any one of the following:

   1. Score at least in the moderate range on self-report anxiety questionnaire
   2. Score at least in the moderate range on self-report depression questionnaire
   3. Report of suicidal thoughts in the past week
   4. Report of engagement in non-suicidal self-injury in the past week

8. Not expected to require inpatient level of care within the next two weeks (as judged clinically)

Exclusion Criteria

1. Documented psychotic disorder (or current, clinically significant psychotic symptoms) that render the patient inappropriate for outpatient level of care or participation in group therapy (as judged clinically by study staff)
2. Current imminent suicide or homicide risk (as judged clinically by study staff)
3. Unwilling or unable to provide consent for study staff to access subject's medical records and coordinate care and exchange data with clinical staff at the Addiction Recovery Management Service
4. Unwilling or unable to identify an emergency contact

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unified Protocol + Treatment As Usual	Unified Protocol (UP)	Participants in this arm are offered 16 twice-weekly group UP sessions in addition to TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders.
Unified Protocol + Treatment As Usual	Treatment as Usual (TAU)	Participants in this arm are offered 16 twice-weekly group UP sessions in addition to TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders.
Treatment As Usual Alone	Treatment as Usual (TAU)	Participants in this arm undergo TAU at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders.

Primary Outcome Measures

Name	Time	Method
Feasibility of Adding UP Group Intervention to TAU	8-week treatment period	Percentage of participants who dropout from treatment during the 8 week study period in the UP+TAU condition will be compared to the percentage of those who drop out from treatment in the TAU condition.
Acceptability of Adding UP Group Intervention to TAU	At the end of the 8-week treatment period	Participants in the UP condition will complete the Client Satisfaction Questionnaire (CSQ-8) at post-treatment to assess acceptability of and satisfaction with the experimental intervention. Range of the scale is 8 (minimum) to 32 (maximum), with higher scores indicating greater levels of satisfaction with treatment received.

Secondary Outcome Measures

Name	Time	Method
Depressive Symptoms Scale (ODSIS)	At the end of the 8-week treatment period	Measured with the Overall Depression Severity and Impairment Scale (ODSIS) at post-treatment. Total scores range from 0-20; higher scores indicate higher levels of depressive symptoms.
Number of Participants Who Reported Nonsuicidal Self-injury in the Past Month	At the end of the 8-week treatment period	Measured with the Self-Injurious Thoughts and Behaviors Interview (SITBI) at post-treatment.
Suicidal Ideation	At the end of the 8-week treatment period	Measured with the Beck Scale for Suicidal Ideation (BSI) at post-treatment. Total scores range from 0-38; higher scores indicate higher levels of suicidal ideation.
Commitment to Sobriety	At the end of the 8-week treatment period	Measured with the Commitment to Sobriety Scale (CSS) at post-treatment. Total scores range from 5-30; higher scores indicate higher levels of commitment to sobriety.
OASIS	At the end of the 8-week treatment period	Overall Anxiety Severity and Impairment Scale (OASIS) administered at post-treatment. Total scores range from 0-20; higher scores indicate higher levels of anxiety.
Substance Craving	At the end of the 8-week treatment period	Measured with a three-item craving scale at post-treatment. Total scores range from 0-27; higher scores indicate higher levels of substance craving.
Percentage of Past 30 Days Abstinent From Substances	At the end of the 8-week treatment period	Operationalized with the percentage days abstinent (PDA) in the past 30 days, measured via Timeline Follow Back (TLFB) at post-treatment.

Trial Locations

Locations (1)

Massachusetts General Hospital Addiction Recovery Management Service; 🇺🇸 Boston, Massachusetts, United States